Irritation has been building between the Office of Generic Drugs (OGD) and industry over the use of the terms backlog vs. workload, particularly over the last few months. At the recent Annual Meeting of the Association for Accessible Medicines (AAM), formerly the Generic Pharmaceutical Association (GPhA), the semantics pot almost boiled over. So why the […]
The FDA published a recertification of its Manual of Policy and Procedure (MaPP) titled, “Good Review Practices”, MaPP 6025.1 yesterday. The first iteration of this document was issued in 2006. This is its second recertification. In reviewing the document, I was reminded of several calls and discussions I have recently had with my industry colleagues […]
In a Federal Register Notice published today, FDA announced that the direct final rule on “Use of Ozone Depleting Substances” published on October 26, 2016 is “excluded from the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled ‘Regulatory Freeze Pending Review,’ this action confirms the effective date […]
The first two and a half months of calendar year 2017 saw the FDA approving 7 first-time generic products. The First Generic Approval reports are always good news for OGD, as these represent (in many cases) products that received priority review as first generics. It is also good news for consumers, as upon their […]
We are pleased to announce that Sharif Ahmed has accepted the position of Principal Consultant in the Regulatory Practice at Lachman Consultants, effective February 20, 2017. Mr. Ahmed has been functioning as a Senior Associate in the Regulatory Practice at Lachman Consultants since January 2016. He is a seasoned Regulatory professional with nearly 30 years […]
Dr. Kathleen “Cook” Uhl, Director, Office of Generic Drugs told the story of the past, present, and future of GDUFA and how the industry and OGD are doing. Interestingly, she noted this was the first meeting she had attended where she heard that industry members said they are happy! Then she noted “you are not […]
Today, at the Generic Pharmaceutical Association (GPhA) Annual Meeting, Chip Davis, the CEO of the “former” GPhA announced the rebranding of the association to its new name, the Association for Accessible Medicines (aam). The change is designed to further the work of the industry group to provide more affordable medicines in both the generic and […]
As we mentioned in previous posts here and here, the new program fee to be instituted as part of GDUFA II and how much you have to pay may be dictated by your diligence in participation in the program fee clean-up currently underway at FDA. This process is designed to identify affiliates of firms, so […]
A memo and its attachments was issued on February 6, 2017 to give various position classes, including pharmacist, consumer safety officers, microbiologists, chemists, medical officers, etc., which cover many of the FDA position classifications. Also, there is no freeze of the hiring of Commissioned Corps Officers of the United States Public Health Service. Hopefully, this […]
Seems like every day we see new proposed legislation being introduced into another state’s legislature. Each one seems to have a somewhat different methodology or focus for controlling and reporting on drug prices. Let’s think about this. Everyone wants to strive for lower drug prices. Remember, in the early 1980’s, the entire nation was focused […]
